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Monitor activities conducted by clinical investigative sites to ensure successful execution of the
Ensure adherence to federal regulations, applicable local regulations, GCPs, ICH Guidelines, SOPs
Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4
Oversee activities of site personnel and motivate/influence them to meet study objectives
Proactively manage sites and ensure action plans are implemented as needed
Ensure regulatory inspection readiness at assigned clinical sites

Appropriate tertiary qualification, health-related (e.g., Medical, Scientific, Nursing) preferred
Minimum of 1 year of clinically-related experience
At least 6 months preferable in independent clinical research monitoring or experience as a Study
Experience in on-site monitoring of investigational drug or device trials is required
Current in-depth knowledge and understanding of therapeutic indications as they relate to clinical
Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and

Clinical Research Associate I

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